Self-management of oral anticoagulation in elderly patients - effects on treatment-related quality of life.

UNLABELLED: BACKGROUND - RATIONALE FOR STUDY: In elderly patients, long-term self-management of oral anticoagulation has been shown to reduce the number of major thromboembolic and bleeding complications and improve the quality of oral anticoagulation (OAC) control compared to routine care for a mean follow-up period of three years. This article presents the results of the predefined secondary endpoint treatment-related quality of life (QoL). METHODS AND RESULTS: The effect of self-management on five aspects of QoL was evaluated in comparison with routine care. A validated questionnaire specifically designed for patients receiving OAC was used. The evaluation was possible for 141 patients, comprising 90% of surviving patients on OAC. At baseline, all patients had high scores for the following QoL-aspects: general treatment satisfaction, self-efficacy, daily hassles and strained social network. A high proportion of patients in both groups explicitly reported high distress, indicating that general psychological distress seems to be of particular concern in this population. After about 3 years of follow-up, patients performing self-management showed a significantly greater improvement in general treatment satisfaction than controls (median score increase [25th percentile, 75th percentile]: 0.9 [0.0, 1.6] vs. 0.0 [-0.2, 0.6], p=0.002; scale 1-6). Changes in general psychological distress, self-efficacy, daily hassles and strained social network were not significant. CONCLUSION: Treatment related quality of life in elderly patients performing self-management of OAC was similar as for patients in routine care setting, with a tendency of higher general treatment satisfaction, after three years of follow up.

Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial.

Although many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N = 99) or routine care group (RCG) (N = 96). The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 +/- 1.2 and 3.0 +/- 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p = 0.049). The post-hoc analysis on OAC treatment sensitivity supported the benefit of self-management (HR 0.27; 95% CI: 0.13 to 0.71; p = 0.006). Fifteen patients in the SMG died during the study, but none of the deaths was directly associated with anticoagulation therapy. In the RCG, 11 patients died; of those, three deaths were directly associated with anticoagulation therapy and there was one death of unknown cause. During follow-up, the quality of OAC control was significantly better in the SMG than in the RCG. In elderly patients, long-term self-management of oral anticoagulation is superior for the prevention of major thromboembolic and bleeding complications and for the quality of oral anticoagulation control compared to routine care for a mean follow-up period of three years.

A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach.

BACKGROUND: In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients' self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. METHODS: In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio and the CoaguChek S system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. RESULTS: A lower rate of clinically relevant disagreements according to Anderson's criteria was found with CoaguChek S than with INRatio without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S, whereas with INRatio we found more differences with a moderate clinical relevance. A high rate of patients' satisfaction with both of the point of care devices was found with only marginal differences. CONCLUSIONS: A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial.

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.